Voltaren solution for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

diclofenac (diclofenac sodium)

Available from:

Lek Pharmaceuticals d.d.

ATC code:

M01AB05

INN (International Name):

diclofenac (diclofenac sodium)

Dosage:

25mg/ml

Pharmaceutical form:

solution for injection

Units in package:

(5) ampoules 3ml

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-06-28

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF THE MEDICINAL PRODUCT
Voltaren® solution for injections
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The active ingredient is
sodium-[o-[(2,6-dichlorophenyl)-amino]-phenyl]-acetate) (diclofenac
sodium).
Each 3ml ampoule contains 75mg diclofenac sodium Ph.Eur.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORMS
Solution for injection in ampoules.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_Ampoules for im use_:
The ampoules are effective in acute forms of pain, including renal
colic, exacerbations of osteo- and
rheumatoid arthritis, acute back pain, acute gout, acute trauma and
fractures, and post-operative pain.
_Ampoules used in intravenous infusion_:
For treatment or prevention of post-operative pain in the hospital
setting.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Undesirable effects may be minimised by using the lowest effective
dose for the shortest duration
necessary to control symptoms (see section 4.4 Special warnings and
precautions for use).
ADULTS
Voltaren
®
ampoules (given im or iv) should not be given for more than two days;
if necessary, treatment
can be continued with Voltaren
®
tablets or suppositories.
Intramuscular injection: The following directions for intramuscular
injection must be adhered to in order
to avoid damage to a nerve or other tissue at the injection site.
One ampoule once (or in severe cases twice) daily intramuscularly by
deep intragluteal injection into the
upper outer quadrant. If two injections daily are required it is
advised that the alternative buttock be
used for the second injection. Alternatively, one ampoule of 75mg can
be combined with other dosage
forms of Voltaren
®
(tablets or suppositories) up to the maximum daily dosage of 150mg.
Renal colic: One 75mg ampoule intramuscularly. A further ampoule may
be administered after 30
minutes if necessary. The recommended maximum daily dose of Voltaren
®
is 150mg.
_Intravenous Infusion_: Immediately before initiating an intravenous
infusion,